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CTRI Number  CTRI/2023/08/056702 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 17/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Attitude, acceptance and productiveness among adult tobacco users after a brief tobacco intervention by dentist - a randomized double blinded controlled trial 
Scientific Title of Study   Attitude, receptivity and effectiveness among adult tobacco users after a brief tobacco intervention by dentist - a randomized double blinded controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bandi Blessi Sravya 
Designation  Post graduate 
Affiliation  Sibar institute of dental sciences 
Address  Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9912024099  
Fax    
Email  blessibandi1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Srinivas 
Designation  Professor & HOD 
Affiliation  Sibar institute of dental sciences 
Address  Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9849368466  
Fax    
Email  srinivaspachava@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Potluri Raja Sekhar 
Designation  Assistant professor 
Affiliation  Sibar institute of dental sciences 
Address  Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  7993480971  
Fax    
Email  sekharpotluri91@gmail.com  
 
Source of Monetary or Material Support  
SIBAR Institute of Dental Sciences, Takkellapdu, Guntur, Andhra Pradesh 
 
Primary Sponsor  
Name  Dr L Krishna Prasad 
Address  Sibar institute of dental sciences, takkellapdu, guntur, andhra pradesh 
Type of Sponsor  Other [Private Dental College ( dean)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bandi Blessi Sravya  Sibar institute of dental sciences  room no. 10, department of public health dentistry
Guntur
ANDHRA PRADESH 
9912024099

blessibandi1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SIBAR Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects having tobacco habit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief type of behavioral intervention for tobacco cessation counselling  first day followed by 1st and 2nd week, 1st ,3rd and 6th month from the first visit  
Comparator Agent  Very brief type of behavioral intervention for tobacco cessation counselling  first day followed by 1st and 2nd week, 1st ,3rd and 6th month from the first visit 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1)Subjects with tobacco habits visiting the department of public health dentistry in a dental institute as patient attenders
2)Males aged 25-60 years
3)Those who are willing to participate and gives consent for the study.
 
 
ExclusionCriteria 
Details  1)Due to social barriers, females are excluded from the study.
2)People who are on daily medication for any systemic disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The effectiveness of brief tobacco intervention given by dentist   1st day, 1st & 2nd week, 1st ,3rd & 6th month from the first visit  
 
Secondary Outcome  
Outcome  TimePoints 
The attitudes & receptivity towards the intervention given by dentist  1st day, 1st & 2nd week, 1st ,3rd & 6th month from the first visit  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/11/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A total sample of 120 subjects will be selected from the people having tobacco habits visiting the department of public health dentistry in a dental institute as patient attenders. Subjects will be explained the entire procedure and written consent is obtained from each of them. subjects will be selected based on inclusion and exclusion criteria. The subjects will be randomly categorized into 2 groups by a single investigator using randomization and the groups are named as Group A and Group B containing 60 subjects in each group. All subjects will undergo clinical examination by single investigator and oral health status will be assessed by using modified WHO oral health assessment form (1997). Care will be taken in order to match the Group A and Group B in all the aspects other than the intervention provided. For subjects in group A, Brief tobacco intervention (BI) is given for 15-30 minutes which includes 5A’s approach (who are willing to quit) and 5R’s approach (who are not willing to quit) along with follow-up on 1st and 2nd week, 1st ,3rd and 6th month from the first visit [11,16]. For subjects in group B, very brief tobacco intervention (VBA) is given for < 60 seconds which includes VBA model (ask, advice & act) along with follow-up on 1st and 2nd week, 1st ,3rd and 6th month from the first visit. Collection of data will be done before and after the intervention to both the groups using a questionnaire. Questionnaire is given to obtain assessment of the attitude, receptivity and effectiveness among adult tobacco users towards the role of dentists in tobacco cessation programs, prior to the intervention and post intervention at 6th month by dentist, either through telephone or the subject is asked to attend and report at the dental institute directly. The responses before and after the intervention for both the groups will be analysed and compared to assess the effectiveness of intervention by using statistical tests.

 
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